Cadence Precision Injector, Model 103-0304
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011535 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cadence Precision Injector, Model 103-0304, is a catheter designed for intravascular occlusion, categorized as a temporary intravascular occluding device. It is specifically engineered to deliver contrast media or therapeutic agents with precision during cardiovascular procedures, ensuring accurate placement and controlled release within the vascular system.
This device is intended for single-use in clinical settings such as catheterization labs. It is not sterile at the time of shipment but is packaged to allow for terminal sterilization prior to use. The Cadence Precision Injector, Model 103-0304, is regulated under FDA regulation number 870.4450 and holds an FDA 510(k) clearance as an abbreviated submission. The device is part of a series of catheters designed for intravascular occlusion.
Cadence Precision Injector, Model 103-0304
Frequently asked questions
What is the Cadence Precision Injector, Model 103-0304, used for?
The Cadence Precision Injector, Model 103-0304, is a catheter specifically designed for intravascular occlusion. It is used to deliver contrast media or therapeutic agents with precision during cardiovascular procedures, ensuring accurate placement and controlled release within the vascular system. This makes it ideal for temporary occlusion tasks in catheterization labs.
Is the Cadence Precision Injector, Model 103-0304, sterile when received?
No, the Cadence Precision Injector, Model 103-0304, is not sterile at the time of shipment. It is packaged to allow for terminal sterilization prior to clinical use, ensuring sterility just before deployment in a controlled medical environment.
How is the Cadence Precision Injector, Model 103-0304, intended for use?
The Cadence Precision Injector, Model 103-0304, is intended for single-use in clinical settings, such as catheterization labs. Its design ensures precision and controlled delivery of substances, making it suitable for temporary intravascular occlusion during cardiovascular interventions.
What regulatory pathway does the Cadence Precision Injector, Model 103-0304, follow?
The Cadence Precision Injector, Model 103-0304, is regulated under FDA regulation number 870.4450 and holds an FDA 510(k) clearance as an abbreviated submission. This classification indicates it is deemed substantially equivalent to a legally marketed device and falls under the category of a temporary intravascular occluding catheter.
What medical specialty is the Cadence Precision Injector, Model 103-0304, primarily associated with?
The Cadence Precision Injector, Model 103-0304, is primarily associated with the cardiovascular medical specialty. It is designed for use in procedures that require precise intravascular occlusion, making it a specialized tool for cardiovascular interventions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 103-0304 Ev3 Cadence™ Precision Injector 1ml, Cadence ... - MedicalEcart, CADENCE PRECISION INJECTOR, MODEL 103-0304 (K011535) — FDA 510(k ..., AccessGUDID - DEVICE: Cadence ™ Precision Injector Thread 1 mL Syringe ..., AccessGUDID - DEVICE: Cadence ™ Precision Injector Thread 1 mL Syringe ..., MICRO THERAPEUTICS 103-0304 EV3 Cadence Precision Injector Thread 1mL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011535 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA 510(k) K011535 24 fields · synced Oct 1, 2026